Healthcare Industry News: hemodialysis
News Release - February 2, 2006
First Patient Enrolled in NxStage's FREEDOM Home Daily Hemodialysis StudyPost-market study to quantify clinical benefits and cost savings of daily home-hemodialysis
LAWRENCE, Mass., Feb. 2 (HSMN NewsFeed) -- NxStage Medical, Inc. (Nasdaq: NXTM ), a manufacturer of innovative, portable home hemodialysis systems, announced the enrollment of the first patient in its FREEDOM Study. Sponsored by NxStage, and implemented in collaboration with up to 70 U.S. dialysis clinics and the United States Renal Data System (USRDS), FREEDOM (Following Rehabilitation, Economics, and Everyday Dialysis Outcome Measurements) is a prospective study to quantify the clinical benefits and cost savings of daily therapy administered to Medicare patients with the NxStage System One versus conventional thrice-weekly dialysis. Importantly, it will quantify the impact of daily therapy on hospitalization rates and total annual costs of care for Medicare beneficiaries undergoing hemodialysis. Published U.S. government data estimates the total health care cost burden of a dialysis patient at $65,000 annually, with dialysis services representing approximately 25% of this cost, while the cost of hospitalizations, drugs and physician fees make up more than 50%.
"We believe this study will demonstrate that daily home dialysis therapy, which has been shown to improve clinical outcomes, will also significantly reduce the total costs associated with dialysis patients. This should lead to greater utilization by health care providers of home and daily hemodialysis with the NxStage System One," stated Mr. Jeffrey Burbank, NxStage's Chief Executive Officer. "We are encouraged by the results of a recent internal study by Kaiser Permanente demonstrating that home daily hemodialysis produced an approximate $10,000 savings per year per patient versus traditional in- center therapy. As a result, Kaiser Permanente now encourages daily hemodialysis among its beneficiaries. We expect other providers to follow suit as we capture ongoing clinical and economic data and present it to the medical community," added Mr. Burbank.
The FREEDOM Study is a prospective, multi-center, observational study, which will enroll up to 500 Medicare patients in up to 70 clinical centers over a two year period. "FREEDOM demonstrates a clear commitment by NxStage to better characterize the cost-effectiveness of daily home hemodialysis, using the NxStage System One," stated Bertrand Jaber, MD, Scientific Advisor of the study and Assistant Chair of Medicine at Caritas St. Elizabeth's Hospital in Brighton, Massachusetts. "The value of this study is demonstrated by its comprehensive aims, which are to quantify the impact of daily therapy on hospitalization and total economic costs, but also to confirm the tremendous reported potential benefits of daily therapy on patient quality of life and rehabilitation," added Dr. Jaber. The first patient was enrolled at Hortense and Louis Rubin Dialysis Center, in Troy, New York.
This is the first time that an outcomes study will prospectively compare economic outcomes of more frequent, or "daily," hemodialysis with those of a matched cohort of thrice-weekly in-center patients. "The FREEDOM Study will compare patients using the NxStage System One with a matched cohort of patients from the USRDS patient database treated with traditional in-center thrice weekly dialysis, to help define differences in the cost of care and patient outcomes between the daily home setting and the dialysis clinic setting," said Allan Collins, MD, FACP, Director of the Chronic Disease Research Group and Professor of Medicine at the University of Minnesota. "This study will provide a practical method to provide further insights into more frequent dialysis and its cost-effectiveness," added Dr. Collins. The USRDS database has long been considered one of the leading data sources on the demographics, outcomes, and economic costs of dialysis. Comparing the study group of patients using the NxStage System One to a USRDS database group matched in terms of demographics, co-morbidities, geography, number of years on dialysis, and other key factors, will allow a valuable comparison to be made without the time and cost challenges of a crossover study, in which patients would be followed for a given time on each type of therapy.
Additional clinical sites will be initiated over the coming months. Physicians, dialysis centers, or patients interested in participating in the FREEDOM study should contact Christine Allen, Director of Clinical Research at NxStage at 978-687-4718. More detailed information on the study protocol and entry criteria can be found at http://www.clinicaltrials.gov under Listings.
About NxStage Medical
NxStage Medical, Inc. (Nasdaq: NXTM ) is a medical device company, headquartered in Lawrence, Massachusetts, USA, that develops, manufactures and markets innovative systems for the treatment of end-stage renal disease, or ESRD, and acute kidney failure. For more information on NxStage and its products, please visit the company's website at http://www.nxstage.com.
About End-stage renal disease (ESRD)
End-stage renal disease (ESRD) is the permanent failure of the kidneys to filter the body's wastes. It is most commonly caused by diabetes, hypertension, or genetic disorders. In order to survive, ESRD patients must use some form of therapy to replace the function of the kidneys for the rest of their lives. Currently, over 450,000 patients in the United States suffer from ESRD, and the costs of treating ESRD patients are over $20 billion annually in the U.S. Due to increases in diabetes, hypertension, and the aging of the U.S. population, those figures are projected to double within the next 10-15 years. The most common form of kidney replacement therapy in the United States today is hemodialysis, which is used by over 350,000 patients. The great majority of these patients are treated with conventional, in-center hemodialysis, in which they must travel to a nearby dialysis center three times per week, where they are connected to dialysis machines for treatments lasting approximately four hours, to cleanse their blood.
Today, most patients undergo hemodialysis therapy three times a week in outpatient dialysis centers. This differs significantly from the 24/7 workings of the naturally functioning kidney. Increasingly, clinicians and patients have recognized opportunities for therapy improvements with more frequent, or daily, dialysis. Hundreds of clinical papers have reported on the health and quality of life benefits of hemodialysis done more frequently. The reported benefits include reduced hypertension, reduced cardiac strain and left ventricular hypertrophy, reduced amyloid disease, and improved anemia status, appetite, and quality of life, including the ability to return to work. A summary of the literature discussing these benefits can be found on NxStage's website, http://www.nxstage.com, under Published Literature.
This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this release that are not clearly historical in nature are forward-looking, and the words "anticipate," "believe," "expect," "estimate," "plan," and similar expressions are generally intended to identify forward-looking statements. Examples of these forward-looking statements include statements as to the anticipated positive results of the FREEDOM study, the anticipated objectives, design and enrollment period of the FREEDOM Study, the anticipated demand for NxStage's products, NxStage's goal to be a market leader in home hemodialysis, and further changes in reimbursement. All forward-looking statements involve risks, uncertainties and contingencies, many of which are beyond NxStage's control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance or achievements including market acceptance and demand for NxStage's System One, growth in home hemodialysis, the actual results demonstrated in the FREEDOM study, and certain other factors that may affect future operating results and which are detailed in NxStage's filings with the Securities and Exchange Commission, including Quarterly Report on Form 10Q for the quarter ended September 30, 2005.
In addition, the statements in this press release represent NxStage's expectations and beliefs as of the date of this press release. NxStage anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while NxStage may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, whether as a result of new information, future events, or otherwise. These forward-looking statements should not be relied upon as representing NxStage's expectations or beliefs as of any date subsequent to the date of this press release.
Source: NxStage Medical
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